TDMS Study 05093-01 Pathology Tables
INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)
P-NITROANILINE
NTP Experiment-Test: 05093-01 Report: PEIRPT03
Study Type: CHRONIC Date: 09/12/94
Route: GAVAGE Time: 21:13:06
Facility: Southern Research Institute
Chemical CAS #: 100-01-6
Lock Date: None
Cage Range: All
Reasons For Removal: All
Removal Date Range: All
Treatment Groups: Include All
a Number of animals examined microscopically at site and number of animals with lesion
Page 1
NTP Experiment-Test: 05093-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC P-NITROANILINE Date: 09/12/94
Route: GAVAGE Time: 21:13:06
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE VEHICLE VEHICLE VEHICLE 3 MG/KG 3 MG/KG 3 MG/KG
CONTROL 9 SSAC 15 SSAC 9 SSAC 15 SSAC
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 50 10 10 50 10 10
Scheduled Sacrifice 9 9 10 10
Early Deaths
Accidently Killed 1
Moribund Sacrifice 16 5
Natural Death 4 1 4
Drowned 1
Survivors
Terminal Sacrifice 29 41
Animals Examined Microscopically 50 10 10 50 10 10
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Liver (50) (10) (10) (50) (10) (10)
Clear Cell Focus 2 (4%) 1 (2%)
Eosinophilic Focus 2 (4%) 1 (2%)
Hematopoietic Cell Proliferation 1 (10%) 1 (10%)
Infiltration Cellular, Multifocal, Lymphocyte 1 (10%)
Inflammation, Granulomatous 2 (4%)
Mixed Cell Focus 2 (4%) 6 (12%)
Mixed Cell Focus, Multiple 1 (2%)
Necrosis, Focal 1 (2%)
Necrosis, Multifocal 2 (20%)
Vacuolization Cytoplasmic 2 (4%) 1 (2%)
Centrilobular, Necrosis 1 (2%)
Kupffer Cell, Pigmentation 1 (2%) 1 (10%) 1 (2%)
Sinusoid, Infiltration Cellular,
Polymorphonuclear 1 (2%)
Mesentery (8) (2)
Cyst 1 (13%)
Hemorrhage 1 (13%)
Fat, Necrosis 4 (50%) 1 (50%)
Pancreas (50) (10) (10) (50)
Atrophy, Focal 1 (10%)
Acinus, Atrophy 5 (10%) 4 (8%)
Acinus, Hyperplasia 2 (4%)
Duct, Dilatation 1 (2%) 2 (4%)
Stomach, Forestomach (50) (10) (10) (50)
Diverticulum 1 (10%)
Hyperplasia 23 (46%) 16 (32%)
Stomach, Glandular (50) (10) (10) (50)
Erosion 2 (4%)
Hyperplasia 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 05093-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC P-NITROANILINE Date: 09/12/94
Route: GAVAGE Time: 21:13:06
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE VEHICLE VEHICLE VEHICLE 3 MG/KG 3 MG/KG 3 MG/KG
CONTROL 9 SSAC 15 SSAC 9 SSAC 15 SSAC
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Tongue (1)
Congestion 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (1) (1)
Mineralization 1 (100%)
Abdominal, Thrombosis 1 (100%)
Heart (50) (10) (10) (50)
Mineralization, Multifocal 1 (10%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (50) (10) (10) (50) (1)
Angiectasis 1 (2%)
Capsule, Accessory Adrenal Cortical Nodule 1 (2%) 2 (20%) 1 (2%)
Spindle Cell, Hyperplasia 1 (2%)
X-Zone, Infiltration Cellular, Lipocyte 1 (2%)
Adrenal Gland, Medulla (50) (10) (10) (50) (1)
Hyperplasia 2 (4%)
Pituitary Gland (48) (10) (9) (50) (1)
Congestion 1 (100%)
Pars Distalis, Hyperplasia 9 (19%) 13 (26%)
Thyroid Gland (50) (10) (10) (50) (10)
Ultimobranchial Cyst 1 (2%)
Follicle, Cyst 3 (6%) 2 (4%)
Follicle, Degeneration, Cystic 17 (34%) 5 (50%) 3 (30%) 22 (44%) 7 (70%)
Follicular Cell, Hyperplasia 2 (4%) 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Ovary (47) (10) (10) (50)
Abscess 1 (2%)
Cyst 9 (19%) 2 (20%) 2 (20%) 15 (30%)
Hemorrhage 2 (4%)
Mineralization 1 (10%)
Pigmentation, Hemosiderin 1 (10%)
Uterus (50) (10) (10) (50) (10) (8)
Angiectasis 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 05093-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC P-NITROANILINE Date: 09/12/94
Route: GAVAGE Time: 21:13:06
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE VEHICLE VEHICLE VEHICLE 3 MG/KG 3 MG/KG 3 MG/KG
CONTROL 9 SSAC 15 SSAC 9 SSAC 15 SSAC
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Cyst 1 (2%)
Dilatation 8 (16%) 25 (50%)
Hemorrhage 1 (2%)
Hydrometra 4 (40%) 2 (25%)
Hyperplasia, Cystic 1 (10%) 1 (10%) 1 (10%)
Inflammation, Acute, Suppurative 1 (13%)
Endometrium, Hyperplasia, Cystic 50 (100%) 9 (90%) 9 (90%) 49 (98%) 10 (100%) 8 (100%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (10) (10) (50)
Hypercellularity 6 (12%) 4 (8%)
Hyperplasia 1 (10%)
Lymph Node (50) (10) (10) (50)
Iliac, Hyperplasia 1 (2%)
Mediastinal, Inflammation, Acute, Suppurative 1 (2%)
Renal, Hyperplasia 1 (2%)
Lymph Node, Mandibular (48) (9) (10) (49)
Hyperplasia 2 (4%)
Lymph Node, Mesenteric (50) (9) (10) (47)
Angiectasis 1 (2%) 1 (2%)
Hyperplasia 2 (4%)
Spleen (50) (10) (10) (49) (10) (10)
Atrophy 1 (10%) 1 (10%)
Congestion 2 (20%)
Ectopic Tissue 1 (2%)
Hematopoietic Cell Proliferation 45 (90%) 1 (10%) 43 (88%) 3 (30%)
Pigmentation 6 (12%) 23 (47%)
Pigmentation, Hemosiderin 1 (10%)
Thymus (49) (10) (10) (48)
Atrophy 1 (10%) 1 (10%)
Cyst 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
None
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
None
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 05093-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC P-NITROANILINE Date: 09/12/94
Route: GAVAGE Time: 21:13:06
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE VEHICLE VEHICLE VEHICLE 3 MG/KG 3 MG/KG 3 MG/KG
CONTROL 9 SSAC 15 SSAC 9 SSAC 15 SSAC
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (10) (10) (49)
Hemorrhage 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (10) (10) (50) (10)
Congestion 1 (10%)
Foreign Body 1 (2%)
Hemorrhage 2 (4%)
Infiltration Cellular, Multifocal, Histiocyte 1 (10%) 3 (30%)
Inflammation, Granulomatous 1 (2%)
Pigmentation 2 (4%)
Pigmentation, Hemosiderin, Multifocal 1 (10%) 2 (20%)
Pigmentation, Multifocal 1 (10%)
Alveolar Epithelium, Hyperplasia 2 (4%) 1 (2%)
Pleura, Fibrosis 1 (2%)
Pleura, Foreign Body 1 (2%)
Pleura, Pigmentation, Cholesterol 1 (2%)
Nose (50) (10) (10) (50)
Foreign Body 20 (40%) 1 (10%) 16 (32%)
Fungus 1 (2%)
Inflammation, Acute, Suppurative 18 (36%) 16 (32%)
Glands, Cyst 1 (2%)
Trachea (50) (10) (10) (50)
Inflammation, Subacute 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Ear (1)
Pinna, Infarct 1 (100%)
Eye (1) (2)
Cataract 1 (50%)
Cornea, Inflammation, Subacute 1 (50%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (10) (10) (50) (1)
Casts Protein 4 (40%) 4 (40%)
Infiltration Cellular, Multifocal, Lymphocyte 4 (40%)
Metaplasia, Osseous 3 (6%)
Nephropathy, Chronic 31 (62%) 29 (58%)
Glomerulus, Amyloid Deposition 1 (10%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 05093-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC P-NITROANILINE Date: 09/12/94
Route: GAVAGE Time: 21:13:06
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE VEHICLE VEHICLE VEHICLE 3 MG/KG 3 MG/KG 3 MG/KG
CONTROL 9 SSAC 15 SSAC 9 SSAC 15 SSAC
____________________________________________________________________________________________________________________________________
URINARY SYSTEM - CONT
Renal Tubule, Dilatation 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 05093-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC P-NITROANILINE Date: 09/12/94
Route: GAVAGE Time: 21:13:06
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 30 MG/KG 30 MG/KG 30 MG/KG 100MG/KG 100MG/KG 100MG/KG
9 SSAC 15 SSAC 9 SSAC 15 SSAC
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 50 10 10 50 10 10
Scheduled Sacrifice 9 10 10 9
Early Deaths
Moribund Sacrifice 11 12
Natural Death 5 5 1
Accidently Killed 1 1
Dosing Accident 1 1
Survivors
Terminal Sacrifice 32 32
Animals Examined Microscopically 50 10 10 50 10 10
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Small, Duodenum (49) (1) (50) (10) (10)
Hyperplasia 1 (2%)
Ulcer 1 (2%)
Intestine Small, Jejunum (50) (1) (50) (10) (9)
Hyperplasia 1 (2%)
Liver (50) (10) (10) (50) (10) (10)
Angiectasis 1 (2%)
Clear Cell Focus 1 (2%) 1 (2%)
Cyst 2 (4%)
Eosinophilic Focus 3 (6%) 1 (2%)
Hematopoietic Cell Proliferation 1 (2%) 3 (30%) 1 (10%)
Infiltration Cellular, Multifocal, Lymphocyte 1 (10%)
Mineralization 1 (2%)
Mineralization, Focal 1 (10%)
Mixed Cell Focus 5 (10%) 3 (6%)
Mixed Cell Focus, Multiple 1 (2%)
Necrosis, Focal 2 (4%) 1 (2%)
Necrosis, Multifocal 2 (20%)
Kupffer Cell, Pigmentation 4 (8%) 39 (78%)
Kupffer Cell, Pigmentation, Hemosiderin 1 (10%) 8 (80%) 9 (90%)
Sinusoid, Infiltration Cellular,
Polymorphonuclear 1 (2%)
Mesentery (9) (6)
Cyst 1 (17%)
Hemorrhage 1 (17%)
Inflammation, Subacute 1 (11%)
Fat, Necrosis 5 (56%) 5 (83%)
Pancreas (50) (1) (50) (10) (10)
Acinus, Atrophy 3 (6%) 2 (4%)
Duct, Cyst 1 (10%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 05093-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC P-NITROANILINE Date: 09/12/94
Route: GAVAGE Time: 21:13:06
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 30 MG/KG 30 MG/KG 30 MG/KG 100MG/KG 100MG/KG 100MG/KG
9 SSAC 15 SSAC 9 SSAC 15 SSAC
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Duct, Dilatation 1 (2%)
Stomach, Forestomach (50) (1) (50) (10) (10)
Hyperplasia 10 (20%) 22 (44%)
Stomach, Glandular (50) (1) (50) (10) (10)
Artery, Inflammation, Subacute 1 (2%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (1) (50) (10) (10)
Inflammation, Subacute 2 (4%)
Mineralization 1 (2%)
Epicardium, Inflammation, Acute 1 (100%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (50) (1) (50) (10) (10)
Accessory Adrenal Cortical Nodule 1 (10%)
Atrophy 1 (2%)
Cyst 1 (2%)
Degeneration, Fatty, Focal 1 (10%)
Hypertrophy, Focal 1 (2%) 1 (2%) 1 (10%)
Spindle Cell, Hyperplasia 3 (6%)
X-Zone, Infiltration Cellular, Lipocyte 2 (4%) 1 (2%)
Adrenal Gland, Medulla (50) (1) (50) (10) (10)
Hyperplasia 2 (4%) 2 (4%)
Islets, Pancreatic (50) (1) (50) (10) (10)
Hyperplasia 1 (2%)
Pituitary Gland (48) (1) (48) (9) (9)
Pars Distalis, Cyst 1 (2%)
Pars Distalis, Hyperplasia 8 (17%) 9 (19%)
Thyroid Gland (50) (10) (50) (10) (10)
Inflammation, Subacute 1 (2%)
C-Cell, Hyperplasia, Focal 2 (20%)
Follicle, Cyst 5 (10%) 5 (10%)
Follicle, Degeneration, Cystic 19 (38%) 7 (70%) 20 (40%) 9 (90%) 4 (40%)
Follicular Cell, Hyperplasia 6 (12%) 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 05093-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC P-NITROANILINE Date: 09/12/94
Route: GAVAGE Time: 21:13:06
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 30 MG/KG 30 MG/KG 30 MG/KG 100MG/KG 100MG/KG 100MG/KG
9 SSAC 15 SSAC 9 SSAC 15 SSAC
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Ovary (49) (1) (1) (48) (10) (10)
Abscess 1 (2%)
Angiectasis 1 (2%)
Cyst 11 (22%) 1 (100%) 8 (17%) 1 (10%)
Hemorrhage 1 (2%)
Metaplasia, Osseous 1 (2%)
Uterus (50) (10) (8) (50) (10) (10)
Dilatation 12 (24%) 19 (38%)
Hydrometra 1 (10%) 1 (13%) 2 (20%)
Inflammation, Subacute 1 (2%)
Endometrium, Hyperplasia, Cystic 49 (98%) 9 (90%) 8 (100%) 49 (98%) 10 (100%) 9 (90%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (1) (50) (10) (10)
Hypercellularity 8 (16%) 22 (44%)
Lymph Node (50) (1) (50) (10) (10)
Iliac, Ectasia 1 (2%)
Iliac, Hyperplasia 2 (4%) 1 (2%)
Mediastinal, Hyperplasia 1 (2%) 1 (2%)
Pancreatic, Hyperplasia 1 (2%)
Pancreatic, Pigmentation 1 (2%)
Renal, Hyperplasia 1 (2%) 1 (2%)
Lymph Node, Mandibular (50) (1) (47) (9) (10)
Hyperplasia 1 (2%)
Lymph Node, Mesenteric (49) (1) (45) (10) (10)
Hyperplasia 2 (4%)
Spleen (50) (10) (10) (50) (10) (10)
Angiectasis 1 (2%)
Atrophy 1 (2%)
Congestion 10 (100%) 7 (70%) 10 (100%) 9 (90%)
Hematopoietic Cell Proliferation 47 (94%) 9 (90%) 10 (100%) 48 (96%) 10 (100%) 9 (90%)
Metaplasia, Osseous 4 (8%)
Pigmentation 45 (90%) 49 (98%)
Pigmentation, Hemosiderin 9 (90%) 10 (100%) 10 (100%) 9 (90%)
Thymus (48) (1) (48) (8) (10)
Pigmentation, Cholesterol 1 (2%)
Mediastinum, Foreign Body 1 (100%)
Mediastinum, Hemorrhage 1 (100%)
Mediastinum, Inflammation 1 (100%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
NTP Experiment-Test: 05093-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC P-NITROANILINE Date: 09/12/94
Route: GAVAGE Time: 21:13:06
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 30 MG/KG 30 MG/KG 30 MG/KG 100MG/KG 100MG/KG 100MG/KG
9 SSAC 15 SSAC 9 SSAC 15 SSAC
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
None
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (1) (50) (10) (10)
Rib, Fracture 1 (2%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
None
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (10) (10) (50) (10) (10)
Hemorrhage 2 (4%) 1 (2%)
Hemorrhage, Focal 1 (10%)
Infiltration Cellular, Multifocal, Lymphocyte 2 (20%) 1 (10%)
Infiltration Cellular, Multifocal, Histiocyte 3 (30%) 1 (10%) 2 (20%) 1 (10%)
Infiltration Cellular, Histiocyte 1 (2%)
Pigmentation 1 (2%) 4 (8%)
Pigmentation, Hemosiderin, Multifocal 3 (30%) 1 (10%) 2 (20%) 1 (10%)
Alveolar Epithelium, Hyperplasia 2 (4%) 3 (6%)
Alveolar Epithelium, Hyperplasia, Focal 1 (10%)
Mediastinum, Foreign Body 1 (2%) 1 (10%)
Mediastinum, Inflammation, Acute, Suppurative 1 (2%) 1 (10%)
Nose (50) (1) (50) (10) (10)
Foreign Body 17 (34%) 10 (20%) 1 (10%)
Inflammation, Acute, Suppurative 12 (24%) 12 (24%) 2 (20%)
Nasolacrimal Duct, Dilatation 1 (2%)
Nasolacrimal Duct, Exudate 1 (10%)
Nasolacrimal Duct, Inflammation, Subacute 1 (10%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (1)
Cataract 1 (100%)
Harderian Gland (10) (7)
Hyperplasia 2 (20%) 1 (14%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 10
NTP Experiment-Test: 05093-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC P-NITROANILINE Date: 09/12/94
Route: GAVAGE Time: 21:13:06
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 30 MG/KG 30 MG/KG 30 MG/KG 100MG/KG 100MG/KG 100MG/KG
9 SSAC 15 SSAC 9 SSAC 15 SSAC
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (1) (50) (10) (10)
Casts Protein 5 (50%) 4 (40%)
Infiltration Cellular, Multifocal, Lymphocyte 2 (20%)
Nephropathy, Chronic 37 (74%) 28 (56%)
Renal Tubule, Hyperplasia, Focal 1 (10%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 11
NTP Experiment-Test: 05093-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC P-NITROANILINE Date: 09/12/94
Route: GAVAGE Time: 21:13:06
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE VEHICLE VEHICLE VEHICLE 3 MG/KG 3 MG/KG 3 MG/KG
CONTROL 9 SSAC 15 SSAC 9 SSAC 15 SSAC
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 50 10 10 50 10 10
Scheduled Sacrifice 10 10 10 10
Early Deaths
Natural Death 4 4
Moribund Sacrifice 13 14
Survivors
Terminal Sacrifice 33 32
Animals Examined Microscopically 50 10 10 50 10 10
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Liver (50) (10) (10) (50) (10) (10)
Angiectasis 1 (2%) 1 (2%)
Basophilic Focus 3 (6%)
Clear Cell Focus 6 (12%) 2 (4%)
Clear Cell Focus, Multiple 1 (2%)
Eosinophilic Focus 8 (16%) 4 (8%)
Hematopoietic Cell Proliferation 1 (10%)
Hemorrhage 1 (2%)
Mixed Cell Focus 5 (10%) 9 (18%)
Necrosis, Focal 4 (8%)
Necrosis, Multifocal 1 (2%)
Kupffer Cell, Pigmentation 1 (2%) 1 (2%)
Kupffer Cell, Pigmentation, Hemosiderin 1 (10%)
Mesentery (2) (4) (1)
Fat, Necrosis 2 (50%)
Fat, Necrosis, Focal 1 (100%)
Pancreas (50) (10) (10) (50)
Basophilic Focus 2 (4%)
Acinus, Atrophy 6 (12%) 2 (4%)
Duct, Dilatation 1 (2%)
Stomach, Forestomach (50) (10) (10) (50) (10)
Hyperplasia 21 (42%) 1 (10%) 20 (40%) 1 (10%)
Inflammation, Subacute 1 (10%) 1 (10%)
Stomach, Glandular (50) (10) (10) (50) (10)
Hyperplasia 2 (4%)
Tooth (35) (35)
Dysplasia 35 (100%) 35 (100%)
Inflammation, Subacute 1 (3%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 12
NTP Experiment-Test: 05093-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC P-NITROANILINE Date: 09/12/94
Route: GAVAGE Time: 21:13:06
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE VEHICLE VEHICLE VEHICLE 3 MG/KG 3 MG/KG 3 MG/KG
CONTROL 9 SSAC 15 SSAC 9 SSAC 15 SSAC
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (10) (10) (50)
Inflammation, Subacute 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (50) (10) (10) (50)
Cyst 1 (2%)
Hyperplasia 1 (2%)
Hypertrophy, Focal 8 (16%) 8 (16%)
Vacuolization Cytoplasmic, Focal 1 (10%)
Capsule, Accessory Adrenal Cortical Nodule 2 (4%)
Spindle Cell, Hyperplasia 10 (20%) 13 (26%)
Adrenal Gland, Medulla (50) (10) (10) (50)
Hyperplasia 2 (4%) 1 (2%)
Islets, Pancreatic (50) (10) (10) (50)
Hyperplasia 7 (14%) 1 (10%) 6 (12%)
Parathyroid Gland (49) (10) (10) (47)
Cyst 1 (10%)
Pituitary Gland (48) (9) (8) (47)
Pars Distalis, Cyst 1 (2%)
Pars Distalis, Hyperplasia 1 (2%)
Thyroid Gland (50) (10) (10) (50) (10) (1)
Ultimobranchial Cyst 1 (10%)
Follicle, Cyst 9 (18%) 3 (6%)
Follicle, Degeneration, Cystic 8 (16%) 2 (20%) 2 (20%) 17 (34%) 3 (30%) 1 (100%)
Follicular Cell, Hyperplasia 2 (4%) 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (50) (10) (10) (50)
Granuloma Sperm 2 (4%)
Penis (1)
Developmental Malformation 1 (100%)
Preputial Gland (25) (1) (25) (4)
Inflammation, Subacute 5 (20%) 1 (4%)
Duct, Cyst 23 (92%) 1 (100%) 22 (88%) 4 (100%)
Testes (50) (10) (10) (50)
Angiectasis 1 (2%)
Atrophy 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 13
NTP Experiment-Test: 05093-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC P-NITROANILINE Date: 09/12/94
Route: GAVAGE Time: 21:13:06
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE VEHICLE VEHICLE VEHICLE 3 MG/KG 3 MG/KG 3 MG/KG
CONTROL 9 SSAC 15 SSAC 9 SSAC 15 SSAC
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Mineralization 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (10) (10) (50) (10) (10)
Hypercellularity 1 (2%) 10 (20%)
Lymph Node, Mesenteric (49) (8) (10) (47)
Angiectasis 1 (2%) 3 (6%)
Thrombosis 1 (2%)
Spleen (50) (10) (10) (50) (10) (10)
Atrophy 1 (2%) 1 (2%)
Congestion 1 (10%)
Hematopoietic Cell Proliferation 13 (26%) 2 (20%) 18 (36%)
Pigmentation 1 (2%)
Thymus (46) (10) (10) (47)
Cyst 1 (2%) 4 (40%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (50) (10) (10) (50) (1)
Cyst Epithelial Inclusion 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
None
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
None
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (10) (10) (50) (10) (10)
Embolus, Multiple 1 (2%)
Erythrophagocytosis, Multifocal 1 (10%)
Hemorrhage, Multifocal 1 (10%)
Infiltration Cellular, Multifocal, Histiocyte 2 (20%) 3 (30%)
Pigmentation, Hemosiderin, Multifocal 1 (10%) 3 (30%)
Alveolar Epithelium, Hyperplasia 5 (10%) 3 (6%)
Alveolar Epithelium, Hyperplasia, Focal 1 (10%) 1 (10%)
Nose (50) (10) (10) (50)
Foreign Body 8 (16%) 2 (20%) 7 (14%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 14
NTP Experiment-Test: 05093-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC P-NITROANILINE Date: 09/12/94
Route: GAVAGE Time: 21:13:06
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE VEHICLE VEHICLE VEHICLE 3 MG/KG 3 MG/KG 3 MG/KG
CONTROL 9 SSAC 15 SSAC 9 SSAC 15 SSAC
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM - CONT
Fungus 1 (2%) 3 (6%)
Inflammation, Acute, Suppurative 8 (16%) 6 (12%)
Nasolacrimal Duct, Hyperplasia 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (1) (1)
Cornea, Inflammation, Subacute 1 (100%) 1 (100%)
Harderian Gland (8) (6)
Hyperplasia 3 (38%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (10) (10) (50)
Casts Protein 1 (10%)
Hydronephrosis 1 (2%) 1 (2%)
Inflammation, Acute, Suppurative 1 (2%)
Metaplasia, Osseous 1 (2%) 1 (2%)
Nephropathy, Chronic 38 (76%) 48 (96%)
Cortex, Cyst 1 (2%) 2 (4%)
Renal Tubule, Hyperplasia 1 (2%)
Renal Tubule, Hyperplasia, Multifocal 1 (10%) 3 (30%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 15
NTP Experiment-Test: 05093-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC P-NITROANILINE Date: 09/12/94
Route: GAVAGE Time: 21:13:06
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 30 MG/KG 30 MG/KG 30 MG/KG 100MG/KG 100MG/KG 100MG/KG
9 SSAC 15 SSAC 9 SSAC 15 SSAC
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 50 10 10 50 10 10
Scheduled Sacrifice 10 10 10 10
Early Deaths
Moribund Sacrifice 10 10
Natural Death 3 1
Drowned 1
Survivors
Terminal Sacrifice 36 39
Animals Examined Microscopically 50 10 10 50 10 10
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Small, Jejunum (50) (50) (10) (10)
Hyperplasia 1 (2%)
Liver (50) (10) (10) (50) (10) (10)
Angiectasis 1 (2%) 2 (4%)
Basophilic Focus 2 (4%)
Clear Cell Focus 4 (8%) 3 (6%)
Clear Cell Focus, Multiple, Two 1 (2%)
Developmental Malformation 1 (10%)
Eosinophilic Focus 3 (6%) 2 (4%)
Hematopoietic Cell Proliferation 2 (4%)
Inclusion Body Intracytoplasmic 1 (2%)
Mixed Cell Focus 5 (10%) 2 (4%)
Necrosis, Focal 2 (4%) 3 (6%)
Biliary Tract, Cyst 1 (2%)
Kupffer Cell, Pigmentation 8 (16%) 50 (100%)
Kupffer Cell, Pigmentation, Hemosiderin 5 (50%) 10 (100%) 10 (100%)
Mesentery (6) (1)
Fat, Necrosis 3 (50%)
Pancreas (50) (49) (10) (10)
Basophilic Focus 2 (4%) 1 (2%)
Eosinophilic Focus 2 (4%)
Inflammation, Subacute 1 (2%)
Acinus, Atrophy 4 (8%) 1 (2%)
Artery, Inflammation, Subacute 1 (2%)
Stomach, Forestomach (50) (10) (50) (10) (10)
Erosion 1 (10%)
Hyperplasia 24 (48%) 18 (36%) 1 (10%)
Inflammation, Subacute 1 (10%)
Stomach, Glandular (50) (10) (50) (10) (10)
Erosion 1 (2%)
Inflammation, Subacute 1 (10%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 16
NTP Experiment-Test: 05093-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC P-NITROANILINE Date: 09/12/94
Route: GAVAGE Time: 21:13:06
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 30 MG/KG 30 MG/KG 30 MG/KG 100MG/KG 100MG/KG 100MG/KG
9 SSAC 15 SSAC 9 SSAC 15 SSAC
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Tooth (33) (35)
Dysplasia 33 (100%) 35 (100%)
Inflammation, Subacute 1 (3%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (1) (1)
Abdominal, Aneurysm 1 (100%)
Abdominal, Hemorrhage 1 (100%)
Abdominal, Inflammation, Subacute 1 (100%)
Abdominal, Thrombosis 1 (100%)
Aorta, Inflammation, Subacute 1 (100%)
Heart (50) (50) (10) (10)
Mineralization 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (50) (50) (10) (10)
Hypertrophy, Focal 10 (20%) 12 (24%)
Necrosis 1 (2%)
Capsule, Accessory Adrenal Cortical Nodule 1 (2%) 1 (2%)
Spindle Cell, Hyperplasia 10 (20%) 11 (22%)
Adrenal Gland, Medulla (50) (50) (10) (10)
Necrosis 1 (2%)
Islets, Pancreatic (50) (49) (10) (10)
Hyperplasia 6 (12%) 3 (6%)
Parathyroid Gland (49) (50) (10) (10)
Cyst 1 (10%)
Pituitary Gland (48) (45) (8) (8)
Pars Distalis, Hyperplasia 1 (2%) 1 (2%)
Thyroid Gland (50) (10) (50) (10) (10)
Ultimobranchial Cyst 1 (10%)
Follicle, Cyst 6 (12%) 6 (12%)
Follicle, Degeneration, Cystic 15 (30%) 3 (30%) 10 (20%) 4 (40%) 4 (40%)
Follicle, Foreign Body 1 (2%)
Follicular Cell, Hyperplasia 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 17
NTP Experiment-Test: 05093-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC P-NITROANILINE Date: 09/12/94
Route: GAVAGE Time: 21:13:06
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 30 MG/KG 30 MG/KG 30 MG/KG 100MG/KG 100MG/KG 100MG/KG
9 SSAC 15 SSAC 9 SSAC 15 SSAC
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (50) (50) (10) (10)
Granuloma Sperm 1 (2%) 2 (4%)
Necrosis 1 (2%)
Preputial Gland (27) (2) (19) (2)
Inflammation, Subacute 1 (4%) 1 (5%)
Duct, Cyst 24 (89%) 2 (100%) 18 (95%) 2 (100%)
Prostate (50) (50) (10) (10)
Inflammation, Subacute 1 (2%)
Testes (50) (50) (10) (10)
Necrosis 1 (2%)
Seminiferous Tubule, Dilatation 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (10) (10) (50) (10) (10)
Hypercellularity 22 (44%) 27 (54%)
Hyperplasia 9 (90%) 4 (40%) 10 (100%) 9 (90%)
Necrosis 1 (2%)
Pigmentation, Hemosiderin 8 (80%) 1 (10%) 10 (100%) 6 (60%)
Lymph Node (50) (1) (49) (10) (10)
Inguinal, Hyperplasia 1 (2%)
Lymph Node, Mandibular (49) (48) (10) (9)
Congestion 1 (11%)
Lymph Node, Mesenteric (49) (1) (45) (10) (10)
Angiectasis 3 (6%)
Hyperplasia 1 (2%)
Inflammation, Subacute 1 (2%)
Thrombosis 1 (2%)
Spleen (50) (10) (10) (50) (10) (10)
Atrophy 1 (2%)
Congestion 6 (60%) 10 (100%) 10 (100%) 10 (100%)
Hematopoietic Cell Proliferation 37 (74%) 10 (100%) 10 (100%) 48 (96%) 10 (100%) 10 (100%)
Pigmentation 46 (92%) 50 (100%)
Pigmentation, Hemosiderin 10 (100%) 10 (100%) 10 (100%) 10 (100%)
Thrombosis 1 (2%)
Thymus (49) (47) (8) (10)
Cyst 3 (30%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (50) (2) (50) (10) (10)
Cyst Epithelial Inclusion 1 (2%)
Inflammation, Focal, Subacute 1 (2%)
Epithelium, Hyperplasia, Focal 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 18
NTP Experiment-Test: 05093-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC P-NITROANILINE Date: 09/12/94
Route: GAVAGE Time: 21:13:06
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 30 MG/KG 30 MG/KG 30 MG/KG 100MG/KG 100MG/KG 100MG/KG
9 SSAC 15 SSAC 9 SSAC 15 SSAC
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM - CONT
Subcutaneous Tissue, Edema, Focal 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50) (10) (10)
Cranium, Hypertrophy, Focal 1 (2%)
Skeletal Muscle (2) (1)
Artery, Inflammation, Subacute 1 (50%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
None
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (10) (10) (50) (10) (10)
Infiltration Cellular, Multifocal, Histiocyte 3 (30%) 4 (40%) 4 (40%) 1 (10%)
Pigmentation, Hemosiderin, Multifocal 3 (30%) 4 (40%) 4 (40%) 1 (10%)
Alveolar Epithelium, Hyperplasia 5 (10%) 8 (16%)
Alveolar Epithelium, Hyperplasia, Focal 1 (10%)
Mediastinum, Thrombosis 1 (2%)
Nose (50) (50) (10) (10)
Exudate 2 (20%)
Foreign Body 8 (16%) 4 (8%) 1 (10%)
Inflammation, Acute, Suppurative 8 (16%) 4 (8%) 1 (10%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Harderian Gland (4) (9)
Hyperplasia 1 (11%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (10) (50) (10) (10)
Metaplasia, Osseous 2 (4%)
Nephropathy, Chronic 46 (92%) 39 (78%)
Bowman's Capsule Parietal Layer, Hyperplasia,
Focal 1 (10%)
Cortex, Cyst 12 (24%) 3 (6%) 2 (20%)
Renal Tubule, Dilatation 1 (2%)
Renal Tubule, Hyperplasia 1 (2%)
Renal Tubule, Hyperplasia, Multifocal 1 (10%) 9 (90%) 1 (10%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 19
NTP Experiment-Test: 05093-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC P-NITROANILINE Date: 09/12/94
Route: GAVAGE Time: 21:13:06
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 30 MG/KG 30 MG/KG 30 MG/KG 100MG/KG 100MG/KG 100MG/KG
9 SSAC 15 SSAC 9 SSAC 15 SSAC
____________________________________________________________________________________________________________________________________
URINARY SYSTEM - CONT
Renal Tubule, Necrosis 1 (2%)
Urinary Bladder (50) (10) (50) (10) (10)
Hemorrhage 1 (2%)
Artery, Inflammation, Subacute 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 20
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